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Collagenase Biobank Study

Collagenase Producing Bacteria as a Biomarker and Driver of Diet-induce Colorectal Cancer Recurrence and Metastasis Following Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Finally, patients will undergo nutritional surveys to document their current nutritional intake."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether bacteria in stool, or what they make, may help colon cancer come back after surgery. It is for adults with known or suspected colon cancer who plan to have surgery at the University of Chicago Comprehensive Cancer Center. Researchers will collect stool and blood before and after surgery, and collect tumor tissue to grow cells in the lab.

The purpose of this study is to look at how bacteria present within the stool at the time of surgery and postoperatively may contribute to the development of cancer recurrence after surgery. By collecting stool and blood before and after surgery, the researchers hope to determine if certain types of bacteria, or products that the bacteria produce, promote the development of tumors after surgery. By collecting tumor tissue and growing cell lines, we hope this will help researchers better understand the behavior of these types of tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English.
  • Be age 18 or older. People of all genders, races, and ethnic backgrounds may join.
  • Be able to understand the study and willing to sign a consent form.
  • Have known or suspected colon adenocarcinoma, a type of colon cancer, for which surgery is recommended.
  • Plan to have surgery to remove the cancer at the University of Chicago Comprehensive Cancer Center.
  • Live within 150 miles of that center.

Who can't join

  • Have stage IV colon cancer, meaning it has spread to other parts of the body.
  • Used antibiotics by mouth or through a vein to treat an infection within 30 days of surgery, or used prebiotics (products that feed gut bacteria) within that time.
  • Had chemotherapy or radiation before surgery for this colon cancer, or for another cancer within the past 6 months.
  • Have or have ever had an ileostomy or colostomy, an opening in the belly for stool to leave the body.
  • Are allergic to the study's surgery medicines: neomycin or metronidazole taken by mouth to prepare the bowel, or cefoxitin given through a vein during surgery.
  • Are pregnant.
  • Have a history of inflammatory bowel disease, which causes swelling in the digestive tract.
  • Have had weight-loss surgery or have a history of an eating disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * English speaking. * All genders, races, and ethnicities. * Aged greater or equal to 18 years of age. * Ability to understand and the willingness to sign a written informed consent form. * Diagnosed with a colon adenocarcinoma or presumed adenocarcinoma in which surgical resection is recommended. * Have a planned surgical resection of the colon adenocarcinoma at the University of Chicago Comprehensive Cancer Center. * Reside within 150 miles of the University of Chicago Comprehensive Cancer Center. Exclusion Criteria: * Stage IV colon adenocarcinoma (known metastatic disease). * Intravenous or oral antibiotic exposure within 30 days of surgery to treat an infection. * Prebiotic exposure within 30 days of surgery. * History of neoadjuvant chemotherapy/radiation to treat the primary colon adenocarcinoma. * History of chemotherapy/radiation to treat a separate malignancy within the last 6 months. * History or current ileostomy or colostomy. * Allergy to perioperative medications (oral neomycin/metronidazole for preoperative bowel preparation, intraoperative prophylactic intravenous cefoxitin). * Patients who are pregnant. * Patients with a history of inflammatory bowel disease. * Patients with a history of bariatric surgery. * History of eating disorders.

Study sites (1)

IL